STANDARD CONDOM

Condom

MAYER LABORATORIES

The following data is part of a premarket notification filed by Mayer Laboratories with the FDA for Standard Condom.

Pre-market Notification Details

Device IDK895530
510k NumberK895530
Device Name:STANDARD CONDOM
ClassificationCondom
Applicant MAYER LABORATORIES 1611 TELEGRAPH AVENUE, SUITE 830 Oakland,  CA  94612
ContactDavid P Mayer
CorrespondentDavid P Mayer
MAYER LABORATORIES 1611 TELEGRAPH AVENUE, SUITE 830 Oakland,  CA  94612
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-09-13
Decision Date1989-11-28

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